American Ginseng in Treating Patients With Cancer-Related Fatigue

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Fatigue

Treatments: Dietary Supplement: American ginseng; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00182780

CDR0000440907 (Registry Identifier)

NCCTG-N03CA

NCI-2012-02670 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: American ginseng may help relieve cancer-related fatigue.

PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.

Full description

OBJECTIVES:

Primary

• Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue.

Secondary

• Determine the toxic effects and tolerability of American ginseng in these patients.
• Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (I or II vs III or IV vs unknown), gender (male vs female), baseline fatigue score (4-7 vs 8-10), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cancer

• Experiences cancer-related fatigue, defined as a baseline fatigue score of ≥ 4 on a numerical analogue scale (0-10)

  • Fatigue must be present for ≥ 1 month before study entry

• No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Hemoglobin ≥ 11 g/dL

Hepatic

• SGOT ≤ 1.5 times upper limit of normal (ULN)

Renal

• Calcium ≤ 1.2 times ULN
• Creatinine ≤ 1.2 times ULN

Cardiovascular

• No uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mm Hg and/or systolic BP > 160)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No diabetes, defined as receiving oral hypoglycemics or insulin
• No hypersensitivity to ginseng
• No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient's fatigue
• Not currently under the care of a psychiatrist for documented psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Concurrent epoetin alfa for treatment of anemia allowed

Chemotherapy

• Concurrent chemotherapy allowed except CHOP therapy

Endocrine therapy

• No concurrent chronic systemic steroids

Radiotherapy

• Not specified

Surgery

• More than 4 weeks since prior major surgery

Other

• No prior ginseng capsules for fatigue

  • Prior ginseng-containing teas or drinks purchased at a grocery store allowed

• No concurrent pharmacologic agents for the treatment of fatigue, including any of the following:

  • Psychostimulants

  • Antidepressants

    • Antidepressants used to treat conditions other than fatigue (e.g., hot flashes) are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month

• No concurrent monoamine oxidase inhibitors

• No concurrent full anticoagulation doses of warfarin or heparin

  • A dose of 1 mg/day for preventing catheter clots allowed

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 4 patient groups

Arm I - American ginseng (low dose)

Experimental group

Description:

Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. Quality of life is assessed at baseline, every 2 weeks during treatment, and at the end of treatment. PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months.

Treatment:

Dietary Supplement: American ginseng

Arm II - American ginseng (mid-dose)

Experimental group

Description:

Patients receive oral American ginseng at the mid-dose twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.

Treatment:

Dietary Supplement: American ginseng

Arm III - American ginseng (high-dose)

Experimental group

Description:

Patients receive oral American ginseng at the high dose twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.

Treatment:

Dietary Supplement: American ginseng

Arm IV - Placebo

Other group

Description:

Patients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity. After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.

Treatment:

Other: Placebo